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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K891010
Device Name NR LATEX EXAMINATION GLOVES
Applicant
Universal Bodycare (I) Sdn. Bhd.
102, Jalan Imbi
Kuala Lumpur,  MY 55100
Applicant Contact JASVANT SINGH
Correspondent
Universal Bodycare (I) Sdn. Bhd.
102, Jalan Imbi
Kuala Lumpur,  MY 55100
Correspondent Contact JASVANT SINGH
Regulation Number880.6250
Classification Product Code
LYY  
Date Received02/28/1989
Decision Date 07/14/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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